Nabilone 0.5 MG Oral Capsule for Itching (DISCO-POT Trial)

Phase 3

Waitlist Available

Led By David Collister, MD, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

Awards & highlights

Pivotal Trial

Summary

This trial tests if nabilone, a synthetic cannabis drug, can reduce severe itching in kidney failure patients on hemodialysis. It aims to see if nabilone is effective by affecting the body's itch pathways. Nabilone is a synthetic cannabinoid that has been evaluated in small trials for various conditions, including pain and spasticity.

Eligible Conditions

Itching
Atopic Dermatitis
Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID

Secondary study objectives

Change in health-related quality of life

Change in uremic pruritis severity

Effect of nabilone on sleep quality

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nabilone 0.5mgExperimental Treatment1 Intervention

Subjects will receive nabilone 0.5 mg orally at night for 1 week increased to nabilone 0.5mg orally twice a day for 3 weeks (over-encapsulated). Drug will be dispensed from a central site to other sites and pharmacy personnel will dispense the study medications directly to research personnel or participants. Drug dispensation will coincide with study visits at randomization and crossover and will allow research personnel to reinforced adherence. The study oral medications may be taken at any time of day with food or water, but we will request that participants take it at the same time each day, preferably at night when uremic pruritus symptoms are usually at the worst. If participants have any side effects or intolerability to study drugs, they may decrease the frequency of nabilone or placebo to 1 capsule by mouth once daily, preferably taken at night.

Group II: Oral placeboPlacebo Group1 Intervention

Subjects will receive placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks (over-encapsulated). Drug will be dispensed from a central site to other sites and pharmacy personnel will dispense the study medications directly to research personnel or participants. Drug dispensation will coincide with study visits at randomization and crossover and will allow research personnel to reinforced adherence. The study oral medications may be taken at any time of day with food or water, but we will request that participants take it at the same time each day, preferably at night when uremic pruritus symptoms are usually at the worst. If participants have any side effects or intolerability to study drugs, they may decrease the frequency of nabilone or placebo to 1 capsule by mouth once daily, preferably taken at night.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nabilone 0.5 MG Oral Capsule

2022

Completed Phase 3

~20

Do I qualify?Apply below to find out